Table 1 Patients demographics and baseline characteristics (ITT population)
Placebo (n = 93) | Duloxetine (n = 91) | |
|---|---|---|
Age, (years) | 15.33 (1.42) | 15.74 (1.38) |
Gender, n (%) | ||
Female | 65 (69.89) | 73 (80.22) |
Race, n (%) | ||
Caucasian | 70 (75.27) | 72 (79.12) |
African American | 8 (8.60) | 7 (7.69) |
Asian | 7 (7.53) | 6 (6.59) |
American Indian or Alaska | 0 | 1 (1.10) |
Native Hawaiian or Others | 1 (1.08) | 0 |
Multiracial | 6 (6.45) | 4 (4.40) |
BMI, kg/m2 | 24.10 (5.92) | 24.11 (7.09) |
Country, n (%) | ||
Argentina | 19 (20.43) | 19 (20.88) |
India | 7 (7.53) | 6 (6.59) |
Puerto Rico | 3 (3.23) | 2 (2.20) |
United States | 64 (68.82) | 64 (70.33) |
Time since diagnosis for fibromyalgia, years mean (SD) | 0.38 (1.24) | 0.19 (0.47) |
BPI Average Pain, (0–10) | ||
Average Pain Score | 5.63 (1.531) | 5.68 (1.365) |
worst pain score | 6.87 (1.889) | 7.11 (1.835) |
least pain score | 3.84 (1.974) | 3.67 (2.108) |
Pain score right now | 5.19 (2.295) | 5.18 (2.488) |
BPI interference | ||
General activity | 5.11 (2.343) | 5.23 (2.362) |
Mood | 5.08 (2.638) | 4.89 (2.639) |
Walking ability | 4.55 (2.819) | 4.16 (2.857) |
Normal work | 4.90 (2.533) | 4.65 (2.614) |
Relations with other people | 3.73 (2.840) | 3.71 (2.778) |
Sleep | 5.60 (3.047) | 5.89 (2.877) |
Enjoyment of life | 4.29 (2.831) | 4.04 (3.080) |
School work | 4.26 (3.240) | 4.86 (3.046) |
BPI average interference Score (0–10) | 4.69 (2.186) | 4.68 (2.194) |
PPQ score (0–100) | ||
Average pain score | 57.51 (21.867) | 61.45 (19.832) |
Worst pain score | 74.43 (21.295) | 77.57 (20.005) |
Pain score right now | 51.16 (25.831) | 49.91 (27.285) |
CGI-S Score (1–7) | ||
Overall | 4.1 (0.8) | 4.1 (0.9) |
Mental illness | 2.03 (1.146) | 2.11 (1.224) |
FDI total score (0–60) | ||
Child total score | 21.93 (10.046) | 23.45 (11.129) |
Parent total score (0–60) | 22.12 (10.710) | 22.87 (11.485) |
CDI total score (0–54) | 12.97 (7.645) | 13.56 (7.078) |
MASC total score (0–117) | 43.61 (18.797) | 45.56 (16.818) |
Current medical status, Yes, n (%) | ||
Major depressive disorder | 15 (16.13) | 17 (18.68) |
Generalized anxiety disorder | 6 (6.45) | 10 (10.99) |
Attention deficit disorder | 7 (7.53) | 4 (4.40) |
Concurrent/ongoing Therapy for FM Symptoms | ||
Psychotherapy | 7 (7.5) | 12 (13.2) |
Physical Therapy | 4 (4.3) | 7 (7.7) |